Addressing chronic pain with Focused Acceptance and Commitment Therapy in integrated primary care: findings from a mixed methods pilot randomized controlled trial.

BACKGROUND: Over 100 million Americans have chronic pain and most obtain their treatment in primary care clinics. However, evidence-based behavioral treatments targeting pain-related disability are not typically provided in these settings. Therefore, this study sought to: 1) evaluate implementation of a brief evidence-based treatment, Focused Acceptance and Commitment Therapy (FACT-CP), delivered by an integrated behavioral health consultant (BHC) in primary care; and 2) preliminarily explore primary (self-reported physical disability) and secondary treatment outcomes (chronic pain acceptance and engagement in valued activities). METHODS: This mixed-methods pilot randomized controlled trial included twenty-six participants with non-cancer chronic pain being treated in primary care (54% women; 46% Hispanic/Latino). Active participants completed a 30-min individual FACT-CP visit followed by 3 weekly 60-min group visits and a booster visit 2 months later. An enhanced treatment as usual (ETAU) control group received 4 handouts about pain management based in cognitive-behavioral science. Follow-up research visits occurred during and after treatment, at 12 weeks (booster visit), and at 6 months. Semi-structured interviews were conducted to collect qualitative data after the last research visit. General linear mixed regression models with repeated measures explored primary and secondary outcomes. RESULTS: The study design and FACT-CP intervention were feasible and acceptable. Quantitative analyses indicate at 6-month follow-up, self-reported physical disability significantly improved pre-post within the FACT-CP arm (d = 0.64); engagement in valued activities significantly improved within both the FACT-CP (d = 0.70) and ETAU arms (d = 0.51); and chronic pain acceptance was the only outcome significantly different between arms (d = 1.04), increased in the FACT-CP arm and decreased in the ETAU arm. Qualitative data analyses reflected that FACT-CP participants reported acquiring skills for learning to live with pain, consistent with increased chronic pain acceptance. CONCLUSION: Findings support that FACT-CP was acceptable for patients with chronic pain and feasible for delivery in a primary care setting by a BHC. Results provide preliminary evidence for improved physical functioning after FACT-CP treatment. A larger pragmatic trial is warranted, with a design based on data gathered in this pilot. TRIAL REGISTRATION: clinicaltrials.gov, NCT04978961 (27/07/2021).

Rationale and design of a pilot study examining Acceptance and Commitment Therapy for persistent pain in an integrated primary care clinic.

Most of the 100 million Americans with persistent pain are treated in primary care clinics, but evidence-based psychosocial approaches targeting pain-related disability are not usually provided in these settings. This manuscript describes the rationale and methods for a protocol to pilot test the feasibility and effectiveness of Acceptance and Commitment Therapy (ACT), an evidence-based psychological treatment for persistent pain, delivered by a Behavioral Health Consultant in primary care. Eligible patients are identified through electronic health record registries and invited to participate via secure messaging, letters and a follow-up phone call. Participants are also recruited with advertising and clinician referral. Patients agreeing to participate are consented and complete initial assessments, with a target of 60 participants. Randomization is stratified based on pain severity with participants assigned to either ACT or Enhanced Treatment as Usual (E-TAU). ACT participants receive one standardized Behavioral Health Consultation visit followed by three ACT-based group visits and one group booster visit. All patients attend six assessment visits, during which the E-TAU patients are provided with educational pain management handouts based on standard cognitive behavioral treatment of pain. The study aims to determine feasibility and effectiveness of brief ACT for persistent pain delivered by an integrated behavioral health clinician in primary care from pre- to post-treatment, and to examine mechanisms of change in ACT participants. This study, in a "real-world" setting, will lay groundwork for a larger trial. If effective, it could improve treatment methods and quality of life for patients with persistent pain using a scalable approach.